Pub1581 Web

410.
06 Checklist for auditing sterilization
with radiation according to DIN EN ISO 111371:2006

Ref: Device: Date:
Manufacturer:
Auditor: Signature
Name
1. Scope
This checklist is applicable for sterilization procedures with irradiators making use of the radionu-
clides 60Co and 137Cs, or generating accelerated electrons, or generating X-rays by accelerating elec-
trons. Compared with the previous version, EN 552, the scope of ISO 11137-1 has been modified to
This document becomes invalid when printed or filed in any place other than the original storage location.
accommodate requirements for the design of sterilization methods. The particulars with respect to the
determination of the sterilization dose rate as well as dosimetry and dose rate measurement have
been cancelled and are now accommodated in ISO 11137-2 and ISO 11137-3 respectively.
Each user must ensure to work only with the currently valid revision of this document!
This checklist shall be used for assessment of operators of the corresponding sterilization facilities.
Where sterile products are to be included in the companys product spectrum, a sterilization assess-
ment (including assessment of design and validation of sterilization processes) must be carried out
based on at least one product file of a sterile product. For sterile products of risk class III, the docu-
mentation of design and validation must be examined.
Where an assessment of sterilization procedures validation is necessary as a part of the QM assess-
ment for medical products, the present checklist should be applied in case of radiation used as the
sterilizing agent.
2. Responsibilities and authority
Lead Auditor
The lead auditor is responsible for the examination and evaluation of the QM system in respect of the
customers system documentation, the related standards and the ruling according to ISO 13485
and/or the Council Directive 93/42/EWG.
He is responsible for the work of the audit team and for the observance of the DQS processes. In
case where the lead auditor is not a technical expert himself, he should accept the evaluation of the
sterilization validation by the technical expert without any protest.
Technical expert
The expert is responsible for the competent evaluation of the aspects of the QM system that are spe-
cific for a product or a procedure. The assessment of the design documentation, especially those
parts specifying the design and validation of sterilization procedures, is his essential task.
3. Approach to the evaluation

The goal of the assessment is to examine whether the requirements of ISO 11137-1 are fulfilled, or
the satisfactory sterilization with radiation is evidenced in any other way. Any alternatively allowed
procedure designated as such by the ISO 11137-1 shall be accepted.
The present checklist must be used as an instrument for the assessment.
410_06e_Checklist_Sterilization_radiation_ISO-11137-1.docx
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410.06 Checklist for auditing sterilization

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The assessment results must be formulated in the audit report, where a reference to this checklist can
be made.
4. Further applicable documents

Technical file review
Assessment guideline
DIN EN ISO 11137-1 Sterilization of health care products - Radiation - Requirements for design,
validation and routine control of a sterilization process for medical devices and other further applicable
standards referenced.
5. Application of the assessment checklist

The checklist serves for the evaluation of audit results. Every audit requirement should be evaluated
separately.
The evaluation of the documentation and implementation of a standards requirement should be
documented in the column Evaluation in the following way:

1 = fulfilled
2 = partially fulfilled, still acceptable
3 = partially fulfilled, not acceptable
4 = not fulfilled
na = not applicable
The numbering of the questions corresponds to the numbers of the requirements as printed in ISO
11137-1.
6. Audit protocol
Please use the DQS form Findings (Feststellungen). The findings must contain a reference to the
checklist questions. These can be entered in the column Reference (Referenz). Please use the
numbering system of the standard using at least two digits of the requirements number (e.g. 4.2 for
Management Responsibility associated with ISO 11137-1). Additional evidence, such as copies of
manufacturers documentation, should be ordered clearly (e.g. using the numbers).
7. Abbreviations
SAL Sterility assurance level
IQ Installation qualification
OQ Operation qualification
PQ Performance qualification
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4 Quality management systems
4.1 Documentation
4.1.1 Have procedures for the design, validation, routine control and product release from ster-
ilization been specified?
4.1.2 Are all documents and records that are necessary according to ISO 11137-1 reviewed,
approved and controlled*) by the designated personnel (see 4.2.1)?

4.2 Management responsibility
4.2.1 Are responsibilities and authorities for all the requirements of ISO 11137-1 specified and
assigned*) to qualified persons?
4.2.2 Is there a contract agreement about the responsibilities and authorities, in case several
organizations (with separate quality management systems) are involved?
4.3 Product realization
4.3.1- Are procedures for purchasing, identification*) and traceability*) specified?

4.3.2
4.3.3 Is a system for calibration of all equipment and testing instruments specified**)?
4.3.4 Is the metrological aspect of the dosimetry traceable to national or international standards
and is it of a known degree of measurement uncertainty?
4.4 Measurement, analysis and improvement Control of nonconforming product
4.4 Are procedures for the control of nonconforming products, corrections, corrective actions
and preventive actions specified*)?
*) respective applicable parts of ISO 13485

**) respective applicable parts of ISO 13485 or ISO 10012-1
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.1.1 Has the type of radiation to be used been specified?
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5.1.2 For electrons or X-rays: has the energy of electrons been specified?
Is the electron beam energy >10 MeV (accelerated electrons) resp. >5 MeV (X-Rays)? If
yes, is there a documented assessment of the potential for induced radioactivity in the
product? (Section 8)
5.2 Microbicidal effectiveness
5.2 (No normative requirements)

5.3 Material effects

5.3 (Assessment of the effects on the product according to Section 8.1)
5.4 Environmental considerations
5.4 Are there, in the context of carrying out radiation sterilization procedures,
documented evaluations of possible environmental effects and impacts?
specified actions for environmental protection?
specified and implemented measures for monitoring (if identified)?
6 Process and equipment characteristics
6.1 Process
6.1 Have process variables been defined and means for monitoring and controlling them been
determined?
6.2 Equipment
6.2.1 Has the irradiator and its mode of operation been specified? If necessary, has the specifi-
cation of the irradiator been revised (see 12.5.1) and retained for its life cycle?
6.2.2 Is the software used for controlling and monitoring the process developed according to a
quality management system providing documented evidence that the software conforms
to its design intention?
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6.2.3- Does the technical documentation, according to the type of the irradiator, describe the
6.2.5
following aspects?
NOTE: the required aspects depending on the respective radiation facilities are indicated in the fol-
lowing table with the number of the respective standards requirement.
Aspects Type of irradiator

Electron X-Rays
Radia- beam
tion generator
the irradiator and its specifications 6.2.3 a) 6.2.4 a) 6.2.5 a)

the activity, type of radionuclide and its activity, the geome- 6.2.3 b) n. a. n. a.
try of the -radiation source

the characteristics of the beam (electron energy/energy of n. a. 6.2.4 b) 6.2.5 b)

X-rays and, if applicable, average beam current, scan
width and scan uniformity)
Dimensions, materials and construction of the X-ray con- n. a. n. a. 6.2.5 c)

verter
The premises including the location of the irradiator 6.2.3 c) 6.2.4 c) 6.2.5 d)
Means for segregation of irradiated products from non- 6.2.3 d) 6.2.4 d) 6.2.5 e)
irradiated products (10.3, 10.4)
The construction and mode of operation of each relevant 6.2.3 e) 6.2.4 e) 6.2.5 f)
conveyor system
The conveyor paths and range of conveyor speed 6.2.3 f) 6.2.4 f) 6.2.5 g)
Dimensions, materials and construction of irradiation con- 6.2.3 g) 6.2.4 g) 6.2.5 h)

tainers
The method of operation and maintenance of the irradiator 6.2.3 h) 6.2.4 h) 6.2.5 i)
and every relevant conveyor system
The means for indicating the position of the -radiation 6.2.3 i) n. a. n. a.
source
Means of indicating that the electron beam and conveyor n. a. 6.2.4 i) 6.2.5 j)
system are operating
Means for automatically returning the -radiation source to 6.2.3 j) n. a. n. a.
its storage location and for automatically ceasing conveyor

movement in case of a failure of the timer for the process
control, or of the conveyor system
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Means for halting irradiation in case of a failure of the con- n. a. 6.2.4 j) 6.2.5 k)
veyor system which affects the radiation dose.
Means for automatically returning the -radiation source to 6.2.3 k) n. a. n. a.
its storage location and for automatically halting transport

by conveyor or for detection of impacted products, in case
the -radiation source is not at its desired position.
Means for automatically halting transport by conveyor or n. a. 6.2.4 k) 6.2.5 l)

for detection of impacted products, in case of failure of the
electron beam.
7 Product definition
7.1-7.2 Is the product to be sterilized, including packaging materials and modifications (12.5.2) to
the product, its packaging or configuration within the packaging specified?
7.3 Is there a system for monitoring the condition of the products (including their bioburden)
intended for sterilization such that the effectiveness of the sterilization process is not com-
promised? Is the effectiveness of this process demonstrated and does it include the de-
termination of the bioburden according to 11737-1?
7.4 If the sterilization dose for a product family is established, are the requirements of 11737-
2:2005, Clause 4, for the definition product family satisfied?
7.5 If a processing category is defined for the purpose of routine processing, have criteria for
assessment as to whether it is to be included in a processing category been documented?
Have product-related variables affecting the radiation dose and product-related parame-
ters for processing been taken into consideration? Are there documented records of these
assessments (see 4.1.2)?
7.6 Are there periodic documented reviews of the criteria for the inclusion of products or prod-
uct groups in processing categories? Are the results of these reviews recorded (see
4.1.2)?
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8 Process definition
8.1 Establishing the maximum acceptable dose

8.2 Establishing the sterilization dose
8.3 Specifying the sterilization doze and the maximum acceptable dose
8.1.1, Have the maximum acceptable dose and the sterilization dose for the product been estab-
8.2.1,
8.3 lished? Does the product meet its specified functional requirements after treatment with
the maximum acceptable dose throughout its defined lifetime?
8.1.2, Have the following aspects been incorporated into the basic technical requirements for the
8.2.3
determination of the maximum acceptable dose and the sterilization dose?
NOTE: the required aspects regarding the dose are indicated in the following table by the number of
the respective norm requirement.
Aspects Maximum Sterilization

acceptable dose
dose
A facility capable of assessing the product with respect to its 8.1.2 a) n. a.

intended function
A competent microbiological laboratory for the processes of n. a. 8.2.3 a)

determining bioburden according to ISO 11737-1 and sterility
tests according to ISO 11137-2?
A product representative of that to be produced routinely 8.1.2 b) 8.2.3 b)
A suitable radiation source that is capable of precisely and 8.1.2 c) 8.2.3 c)

exactly emitting the required dose (see 8.4.1)
8.2.2 Is one of the following procedures used to determine the sterilization dose:
a) Knowledge of number / radiation resistance of the bioburden is acquired and used
(ISO 11137-2:2006, 6.1)?
b) Establishing a dose of 25 kGy or 15 kGy respectively and confirmation (by evidence
available to the primary manufacturer) that this dose fulfils the specified requirements
for sterility (ISO 11137-2:2006, 6.2)?
8.4 Transference of maximum acceptable, verification or sterilization dose between

radiation sources
8.4.1 Should the maximum acceptable dose be transferred to another radiation source, is a
documented evaluation carried out to prove that the validity of the dose is not impacted?
Are there records of the evaluation results (see 4.1.2)?
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8.4.2ff During the transfer of the verification or sterilization dose, is it controlled that one of the
following conditions is fulfilled?
a) There was evidentiary data proving that changes in the usage conditions of the two
radiation sources had no effect on the effectiveness of sterilization.
b) The dose transfer took place between

a -irradiator and another -irradiator, or
one electron beam generator and another electron beam generator, or
one X-ray generator and another X-ray generator
For products containing water in the liquid state, dose transfer is only permitted
between two radiation sources (electron beam, X-ray) operating under identical
conditions or two -irradiators.
9 Validation
9.1 Installation qualification (IQ)
9.1.1 Have operating procedures for the irradiator and each associated conveyor system been
specified?
9.1.2 Is a documented verification of the procedure and auxiliary materials including software
carried out with respect to operations within the design specifications? Are the results re-
corded (see 4.1.2)?
Are the following aspects determined, documented and recorded (see 4.1.2)?
9.1.3 any modifications made to the irradiator during installation (6.2.1)?
9.1.4 for -irradiators - activity of the source, description of the positions of individual com-
ponents of radiation source?
9.1.5- for electron beam generators and X-ray generators characteristics of radiation
9.1.6
(electron or X-ray energy, average beam current and, if applicable, scan width and
scan uniformity)?
9.2 Operational qualification (OQ)
9.2.1 Is the calibration of all measurement and test instruments confirmed before OQ? (see
4.3.3)
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9.2.2 Is the OQ carried out by irradiating homogenous material representative of the product to
be processed? Are the operational abilities and adequacy of the irradiator adequately
demonstrated defined specified acceptance criteria (Section 8)?
9.2.3- Is dose mapping carried out correctly within material containers as well as within fully
9.2.4
loaded irradiators (using suitable dosimeters and sufficient measurement points for effec-
tive reproducibility)? ( ISO 11137-3)
9.2.5 Is dose mapping carried out on a sufficient number of irradiation containers to allow to
determine the dose variability and distribution between the containers?
9.2.6 Is the dose mapping carried out for each conveyor path used to process product?
9.2.7 Are the effects of an interruption of the process on the dose determined and recorded?
9.2.8 Do the records of dose mapping include the following: Description of the irradiation con-
tainers, operating conditions, used materials, dose measurement, conclusions?
9.2.9 For facilities: Is the relationship between timer settings, the speed of the conveyor sys-
tem and the dose determined?
9.2.10 For electron beam and X-ray irradiators: During dose mapping, do the fluctuations in ra-
diation characteristics (see 9.1.5, 9.1.6) lie within the limiting values according to the irra-
diator specifications (see 6.2.4, 6.2.5)?
9.2.11 For electron beam and X-ray irradiators: Is the relationship between beam characteristics
(see 9.1.5, 9.1.6), speed of the conveyor system and the dose determined?
9.3 Performance qualification (PQ)
9.3.1 Is dose mapping carried out using a product loaded in irradiation containers according to a
specified loading pattern, so that the following can be identified / determined?
a) Location and magnitude of minimum and maximum dose
b) The relationships between the minimum / maximum dose and the dose(s) at the rou-
tine monitoring point(s)
9.3.2 Is the manner of presenting product for sterilization specified, with inclusion of
a) Dimension and density of the packaged product?
b) Orientation of the product within the packaging?
c) Description of the irradiation containers (in case multiple types are used)?
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d) Description of the conveyor paths (in case multiple conveyor paths are used within the
irradiator)?
9.3.3 Is dose mapping carried out for every processing class (7.5)?
9.3.4 If partially filled irradiation containers are used during routine processing, is the effect of
partial filling on dose distribution within irradiation containers as well as on other contain-
ers present within the irradiator determined and recorded (see 4.1.2)?
9.3.5 Are the irradiation containers used for dose mapping representative and sufficient for the
determination of dose fluctuations between containers?
9.3.6 Is dose mapping carried out for each conveyor path used for processing the defined prod-
uct?
9.3.7 For - and X-ray irradiators: is dose mapping carried out to identify products (or, if used,
processing categories) that can be processed with the product being mapped? Are the
effects of the dose on products of different densities determined to define products that
can be processed together?
9.3.8 Are the following aspects included in the records for dose mapping: description of irradia-
tion containers, loading patterns, conveyor path, irradiator operating conditions, dose
measurement, conclusions?
9.4 Inspection and approval of validation
9.4.1- Is the information generated during IQ, OQ and PQ reviewed and the outcome of this re-
9.4.2
view recorded and used as a basis for the process specification? (see 4.1.2)
9.4.3- Does the process specification for the respective type of irradiator contain details to the
9.4.4
following aspects:
NOTE: The required aspects depending on the respective radiation facilities are indicated in the fol-
lowing table with the number of the respective norm requirement.
Aspects Type of irradiator

Electron beam
Radia- generator or X-ray
tion generator
The description of packaged product including dimensions, 9.4.3 a) 9.4.4 a)

density, orientation within the packaging (see Sections 7 and
9.3.2) as well as the acceptable variations?
The loading pattern of the product within the irradiation con- 9.4.3 b) 9.4.4 b)
tainer (see 9.3.1)?
The conveyor path(s) to be used for the product (see 9.3.6)? 9.4.3 c) 9.4.4 c)
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The maximum acceptable dose (see 8.1)? 9.4.3 d) 9.4.4 d)
The sterilization dose (see 8.2)? 9.4.3 e) 9.4.4 e)
For products that support microbial growth: the maximum time 9.4.3 f) 9.4.4 f)
interval between manufacture and the completion of irradia-
tion?
The routine dosimeter position for dose monitoring? 9.4.3 g) 9.4.4 g)
The relationships between the dose at the monitoring posi- 9.4.3 h) 9.4.4 h)
tions and the minimum and maximum doses (see 9.3.1)?

Operating conditions of the irradiator and its limiting values n. a. 9.4.4 i)

(Beam characteristics, conveyor speed)?
For products that are to be exposed to the radiation field more 9.4.3 i) 9.4.4 j)
than once, all required re-orientation between exposures?
10 Routine monitoring and control
10.1 Are procedures specified for handling of the product and maintenance of product integrity
before, during and after irradiation?
10.2 Is the number of products during acceptance, loading and unloading, handling and release
controlled and are all discrepancies in the count resolved prior to release?
10.3 Are all irradiated and non-irradiated products segregated?
10.4 Has it been determined, that radiation sensitive visual indicators are not being used as the
sole proof of adequate radiation processing or as the sole means of differentiating irradi-
ated products from non-irradiated products?
10.5 Is the product loaded into the irradiation container in accordance with the process specifi-
cation (see 9.4.3, 9.4.4)?
10.6- Are dosimeters used at the predetermined routine monitoring position(s) in sufficient fre-
10.7
quency to verify that the process is in control? Are the measured dosimetric results re-
corded (see 4.1.2) and analyzed?
10.8 a) For -irradiators: are the settings of the timer and/or conveyor speed set according to a
documented procedure to take account of nuclide decay?
10.8 b) For -irradiators: Is the position of the -source, the setting of the timer and/or conveyor
speed and the movement of the irradiation container monitored and recorded (see 4.1.2)?
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10.9 For electron beam generators and X-ray irradiators Are the characteristics of the elec-
tron rays (see 9.1.5, 9.1.6) and the conveyor speed monitored and recorded (see 4.1.2)?
10.10 Are all process interruptions and non-conformances as well as all corrective actions taken
against these monitored and recorded (see 4.1.2)?
10.11 Do the records of radiation processing show the date of irradiation and allow the traceabil-
ity of batches (see 4.3.2)?
11 Product release from sterilization

11.1 Before product release, are all specific periodic tests, calibrations, maintenance work and
necessary re-qualifications performed and their results recorded (see 4.1.2)?
11.2 Are procedures for the review of records and product release from sterilization specified?
Do these procedures define the requirements (see 9.4.3/9.4.4) for designating a steriliza-
tion process as one conforming to the standard, taking the uncertainties of the measure-
ment system(s) into account?
If these requirements are not satisfied, is the product considered defective and handled
accordingly (see 4.4)?
12 Maintaining process effectiveness
12.1 Demonstration of continued effectiveness
12.1.1 Is the continued effectiveness of the established sterilization dose demonstrated by de-
termination of the bioburden and inspecting the sterilization?
Is the frequency of determining bioburden maintained as follows?
Condition Frequency of determina-

tion of bioburden
12.1.2.1 Average bioburden 1,5 At least every 3 months
12.1.2.2 Average bioburden 1,5 At least every 3 months

Sterilization dose specified at 25 kGy or Method 2 (15 or 25 kGy, ISO
11137-2) selected (see 8.2.2)
12.1.2.3 Average bioburden 1,5 At least every 30 days

Sterilization dose specified at 25 kGy or Method 1 (according to radia-
tion resistance, 15 or 25 kGy, ISO 11137-2) selected (see 8.2.2)
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12.1.2.4 Time interval between manufacturing of batches is greater than 1 resp. With every manufactured
3 months (see conditions mentioned above) batch
12.1.2.5 In case the result of the determination of bioburden exceeds the specified limit
Is an inspection according to ISO 11737-1 conducted?
Are QM-actions taken and an inspection of the sterilization dose conducted, in case
the bioburden is evidenced in this inspection?
Depending on the result of this inspection, are the following procedures implemented?
Result Procedure
a) Sterilization dose Implementation of measures according to 12.1.3.5

inspection unsuc-
cessful
b) Sterilization dose Continuing sterilization with the dose used prior to the sterilization dose inspection,
inspection suc- keeping with the following auxiliary conditions:
cessful, the
bioburden how- In case of Auxiliary Conditions
ever still exceeds
the specified limit-
ing value 1) The sterilization dose is established Inspection of sterilization dose every
using Method 1 (ISO 11137-2) 3 months until bioburden lies within
the limiting values or a new steriliza-
tion dose is specified
2) The sterilization dose is established Inspection of sterilization dose every

using Method 2 (ISO 11137-2) 3 months until compliance with
12.1.3.2 is achieved
3) A sterilization dose of 25 kGy was se- Continuation of sterilization dose

lected and substantiated using method inspection with current frequency
VDmax25, average bioburden <1000
4) A sterilization dose of 25 kGy was se- Acquiring the sterilization dose by

lected and substantiated using method means of another procedure
VDmax25, average bioburden >1000
5) A sterilization dose of 15 kGy was se- Continuation of sterilization dose

lected and substantiated using method inspection with current frequency
VDmax15, average bioburden <1.5
6) A sterilization dose of 15 kGy was se- Acquiring the sterilization dose by

lected and substantiated using method means of another procedure
VDmax15, average bioburden <1.5
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12.1.3.1 Is one of the following procedures followed in order to establish the frequency of steriliza-
tion dose inspections?
a) A time interval of 3 months between inspections is selected, or
b) An explanatory statement for the selection of the time interval is prepared and docu-
mented, taking into account and making reports of: review and conclusions reached,
with respect to, at least:
1) Specified limiting value for bioburden

2) Available data from determination of bioburden, the time period during which this
data was obtained and the characterization of the microorganisms that comprise
the bioburden
3) Available data on the resistance of microorganisms comprising the bioburden
4) The method used to establish the sterilization dose and the cautionary measures
related to the procedure
5) The difference between the dose used in routine processing and the sterilization
dose, together with a cautionary measure related to this difference
6) The materials of which the product is comprised, especially the usage of materials
of natural origin and the control of microbiological quality of these materials
7) Manufacturing process, especially steps in manufacturing that affect bioburden or

its resistance
8) Control and monitoring procedures for the manufacturing process
9) Time interval between the manufacturing of different product batches
10) The manufacturing environment, especially the extent of microbiological control

and monitoring and available data regarding the stability of the environment of the
manufacturing over time
11) Control of health, cleanliness and clothing of manufacturing personnel
12) Available data regarding the microbiological characteristics of other products in the
same product family
12.1.3.2 On increasing the time interval between inspections of the sterilization dose, are the fol-
lowing conditions fulfilled?
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a) There are at least four consecutive inspections of the sterilization dose conducted in
the previously selected time intervals, whose results have required neither increase
nor reestablishment of the sterilization dose
b) There is data available to prove the stability of bioburden within its specification over
the same time period as above in a). This data includes:
1) Determination of bioburden at least every three months
2) The characterization of bioburden (e.g. the inspection of colonial or cellular mor-
phology, the staining characterizations or the usage of selective culturing)
c) The manufacturing of the product is controlled with respect to bioburden and the effec-
tiveness of this control is demonstrated by implementing the elements of a QM system
for sterile medical products specified in ISO 13485.
Is an inspection of the sterilization dose conducted
12.1.3.4 With every manufactured batch, if the time interval between the manufacturing of the
charges is greater than the specified time interval between sterilization dose inspec-
tions, or
12.1.3.3 At least every 12 months?
12.1.3.5 If the sterilization dose inspection is unsuccessful, are measures in accordance with
ISO 11137-2:2006, Section 10 implemented? Is a sterilization dose inspection conducted
every 3 months, until one of the following conditions is fulfilled?
a) The cause of failure of the sterilization dose audit or the increase in bioburden is in-
vestigated and corrections and/or corrective actions are implemented.
b) The rationale for the time interval (12.1.3.1) is investigated, and, if necessary, a new
time interval is determined.
c) The criteria for increasing the time interval according to 12.1.3.2 are fulfilled.
12.2 Recalibration
12.2 Are the accuracy and reliability of all instruments used to control, indicate or record the
sterilization process verified periodically (see 4.3.3)?
12.3 Maintenance of equipment
12.3.1- Is there a documented procedure for planning and performing preventive maintenance?
12.3.2
Are records regarding this retained (see 4.1.2)? Is a documented inspection for the main-
tenance plan / measures / records periodically conducted by a designated person and its
result evaluated?
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12.4 Requalification of equipment
12.4.1 Is a documented requalification of the sterilization process conducted within a rationalized

extent and according to an specified procedure for specified products / equipment:
At defined time intervals?
After assessment of any change (12.5)?
12.4.2- Are requalification procedures specified and records of requalification retained (see
12.4.3
4.1.2)? Is requalification data reviewed against specified acceptance criteria in accor-

dance with documented procedures and the records of the reviews (see 4.1.2) retained,
together with any corrections made and/or corrective actions taken (such as when the
specified acceptance criteria are not met)?
12.5 Assessment of change
(to the irradiator / of product / product release from sterilization)
12.5.1 For any change to the radiation facility that could impact the dose or dose distribution, is
an assessment carried out? Is there a revalidation (IQ, OQ and/or PQ, see 9.1-9.3) in
case of such impacts? Is the outcome of the assessment recorded, including the rationale
for the decisions reached (see 4.1.2)?
12.5.2 For any change to a product, its packaging or the presentation of a product for steriliza-
tion, is there a documented (see 4.1.2) assessment of its effects on the appropriateness of
the sterilization process? Are those parts of process definition or PQ that have to be un-
dertaken determined based on the nature of the change? Is the outcome of the assess-
ment, including the rationale for the decisions reached, recorded?
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410.

06 Checklist for auditing sterilization

with radiation according to DIN EN ISO 111371:2006

2. Responsibilities and authority

3. Approach to the evaluation

with radiation according to DIN EN ISO 111371:2006

4. Further applicable documents

5. Application of the assessment checklist

documented in the column Evaluation in the following way:

with radiation according to DIN EN ISO 111371:2006

approved and controlled*) by the designated personnel (see 4.2.1)?

4.2 Management responsibility

4.3 Product realization

4.3.1- Are procedures for purchasing, identification*) and traceability*) specified?

4.4 Measurement, analysis and improvement Control of nonconforming product

*) respective applicable parts of ISO 13485

5 Sterilizing agent characterization

5.1 Sterilizing agent

5.1.1 Has the type of radiation to be used been specified?

with radiation according to DIN EN ISO 111371:2006

5.2 Microbicidal effectiveness

5.2 (No normative requirements)

5.3 Material effects

5.3 (Assessment of the effects on the product according to Section 8.1)

5.4 Environmental considerations

6 Process and equipment characteristics

with radiation according to DIN EN ISO 111371:2006

Aspects Type of irradiator

the irradiator and its specifications 6.2.3 a) 6.2.4 a) 6.2.5 a)

try of the -radiation source

the characteristics of the beam (electron energy/energy of n. a. 6.2.4 b) 6.2.5 b)

Dimensions, materials and construction of the X-ray con- n. a. n. a. 6.2.5 c)

Dimensions, materials and construction of irradiation con- 6.2.3 g) 6.2.4 g) 6.2.5 h)

The means for indicating the position of the -radiation 6.2.3 i) n. a. n. a.

Means for automatically returning the -radiation source to 6.2.3 j) n. a. n. a.

its storage location and for automatically ceasing conveyor

with radiation according to DIN EN ISO 111371:2006

Means for automatically returning the -radiation source to 6.2.3 k) n. a. n. a.

its storage location and for automatically halting transport

Means for automatically halting transport by conveyor or n. a. 6.2.4 k) 6.2.5 l)

with radiation according to DIN EN ISO 111371:2006

8.1 Establishing the maximum acceptable dose

Aspects Maximum Sterilization

A facility capable of assessing the product with respect to its 8.1.2 a) n. a.

A competent microbiological laboratory for the processes of n. a. 8.2.3 a)

A product representative of that to be produced routinely 8.1.2 b) 8.2.3 b)

A suitable radiation source that is capable of precisely and 8.1.2 c) 8.2.3 c)

8.4 Transference of maximum acceptable, verification or sterilization dose between

with radiation according to DIN EN ISO 111371:2006

b) The dose transfer took place between

conditions or two -irradiators.

9.1 Installation qualification (IQ)

9.1.3 any modifications made to the irradiator during installation (6.2.1)?

9.2 Operational qualification (OQ)

with radiation according to DIN EN ISO 111371:2006

9.3 Performance qualification (PQ)

a) Location and magnitude of minimum and maximum dose

a) Dimension and density of the packaged product?

b) Orientation of the product within the packaging?

with radiation according to DIN EN ISO 111371:2006

9.4 Inspection and approval of validation

Aspects Type of irradiator

The description of packaged product including dimensions, 9.4.3 a) 9.4.4 a)

with radiation according to DIN EN ISO 111371:2006

4.3.1- Are procedures for purchasing, identification) and traceability) specified?